State, Regence tighten access to popular cholesterol drug

It's the No. 1 prescription drug in the nation, thanks to aggressive and expensive advertising and sales fueled by aging baby boomers with creeping cholesterol levels.

But Lipitor's grip on the market will soon be attacked by both the state government and Regence BlueShield, Washington's second-largest health insurer, which next month will begin forcing new patients to try dramatically cheaper new generic drugs first. Even state workers who already take Lipitor will have to cough up higher co-payments if they insist on keeping it in their medicine cabinets.

Drug makers call it meddling with doctors' autonomy to do what's best for their patients. But insurance experts say it's only the latest example of a growing practice: private and public insurers who rely on clinical evidence to steer doctors toward preferred — often less expensive — medications first.

Called "step therapy," it forces patients to try generics, and even cheaper brand-name drugs, before insurers will pay for expensive brands, if at all. The idea is to give a therapeutically comparable drug a chance to work before opting for the more expensive medication.

"Effective marketing doesn't necessarily mean better," said SuAnn Stone, director of pharmacy services for Seattle-based Regence BlueShield. "It just means new and more expensive."

Cheaper generics

Step therapy for Lipitor and other cholesterol drugs, called statins, will go into effect April 1 for people covered by the Uniform Medical Plan for state employees and Washington's Medicaid program and on April 3 for 1.1 million Regence members in Washington.

In most cases, new patients will have to show that they have tried at least two other statins favored by the insurer before they seek coverage for Lipitor.

Patients already on Lipitor will be exempt from the changes. But some state workers and retirees could see their co-pays double for Lipitor, even for renewals for existing prescriptions.

The changes are meant to capitalize on last year's introduction of two generic statins, pravastatin and simvastatin, whose average prices are as much as 80 percent less than for Lipitor. A generic version of Lipitor won't be available for several years because its manufacturer, Pfizer, still holds the patent.

Lipitor a last resort

In 2005, American doctors wrote $8.4 billion worth of prescriptions for Lipitor, about twice as much as for Zocor, its closest competitor. In Washington, Lipitor is the biggest drug expense for the Uniform Medical Plan, which covers half of the 322,000 state and public-school employees. It's also the fifth-biggest drug expense for Medicaid adults — Washington Medicaid spends more money only for psychiatric drugs.

Though prescription drugs account for a small portion of the nation's health-care spending, the costs are among the fastest-growing. Insurers — and patients — can save millions of dollars immediately by turning to generics and "preferred" brand-name drugs, often cheaper drugs that insurers deem equally effective.

In January, the Uniform Medical Plan launched its step-therapy program with 10 drug classes. Patients with conditions such as arthritis, asthma, herpes and insomnia must try — and fail — on at least one other drug before receiving coverage for the nonpreferred drug.

Still, patients such as Jeff Sutton, of Seattle, remain Lipitor loyalists despite its comparatively hefty price.

When his doctor prescribed statins three years ago, Sutton chose Lipitor even though his insurance company, Regence, already required a higher co-pay for it. Sutton said his cholesterol level has fallen by nearly 40 percent.

Though he will be exempt from Regence's latest policy, Sutton worries that it's another step closer to curtailing patients' choice. He wonders whether Regence will eventually make it difficult for him to stay on Lipitor at any price.

"I'd be worried about the side effects" as well as the more-frequent blood checks required when switching statins, said Sutton, 42, who is the vice president of a Seattle aviation-insurance firm.

Regence's Stone says such concerns are unwarranted. The vast majority of statin takers have low or moderate cholesterol levels that can be treated effectively with generics, she said.

So starting April 3, that will become the required first step for Regence members in Washington with new statin prescriptions. Regence has already put the change into effect for its members in Oregon, Idaho and Utah.

If the generics don't do the job, doctors will have to submit to Regence the patient's "bad" cholesterol level and the target goal to get approval to try two brand-name statins, Crestor or Vytorin. Regence will pay for Lipitor only as a last resort.

The Uniform Medical Plan for state workers is adopting a similar step therapy, except that it is also raising co-pays for current Lipitor patients. For a 90-day mail order for Lipitor, the co-pay will double to $100 after April 1.

For Medicaid patients, Lipitor will no longer be the "preferred" high-potency statin after next month. Doctors will have to prescribe Crestor instead, unless they are allowed by Medicaid to instruct pharmacists to "dispense as written." Otherwise, the doctor will have to call Medicaid for prior authorization for Lipitor.

Drugmaker opposition

Drug manufacturers oppose such restrictions because they prevent doctors from prescribing the most appropriate medications for their patients, said Jennifer Van Meter, director of clinical medical policy for Pharmaceutical Research and Manufacturers of America, a trade group that includes Pfizer.

"Physicians should have the autonomy to treat their patients," Van Meter said.

Dr. William Golden, a member of the board of regents of the American College of Physicians, a Philadelphia-based national organization, said cheaper statins such as Mevacor (known generically as lovastatin) are not often his first choice for patients for various reasons, including effectiveness and toxicity.

Still, Golden said, physicians are resigned to insurers' increasing insistence on step therapy.

"The risk of compromising patient care is fairly small" with substitutes, Golden said. "The value of Lipitor does not stand up to that kind of cost differential."

Even so, doctors ultimately get the final say on their patients' medications, said Jim Carlson, pharmacy director for Seattle's Group Health Cooperative, which has used such clinical guidelines for drugs for years.

Group Health reserves Lipitor for patients with high cholesterol by limiting coverage to the 80-milligram high dose. But Carlson says that if a doctor can medically justify needing a different dose, or a different drug, Group Health will allow it.

Still, Carlson predicts that thousands of Lipitor users will be weaned off the drug as the policies take effect and other insurers follow.

"At the end of the day, patients want what their [health] plans cover," he said.

Kyung Song: 206-464-2423 or ksong@seattletimes.com